GET TESTED INTERNATIONAL AB recalled 8 Fructose Intolerance Test devices distributed nationwide in the United States. The recall cites distribution without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions.
Distribution without premarket approval/clearance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
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The Fructose Intolerance Test is a diagnostic device intended to assess fructose intolerance. The recall concerns distribution of the device without premarket approval or clearance in the United States.
The device was distributed without FDA premarket approval or clearance, a regulatory violation that may affect safety assessments. The recall emphasizes stopping use and following manufacturer instructions.
This recall is not part of a broader industry pattern.
Consumers and clinicians who received the device may be affected by regulatory noncompliance. There were no injuries reported in the recall notice. Immediate action advised.
Packaging, recall notification letter, and any accompanying documentation.
Not specified. Typical recall processing may take 4-6 weeks.
Keep the recall letter, product packaging, model numbers, lot numbers, dates of purchase, and all correspondence with the manufacturer.
Model numbers: EAN 616612787323; SKU 2B120; UDI-DI: None; Lot/Serial Number: All Lots. Sold: US Nationwide distribution. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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